Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males

NCT02265302 | Completed Phase 1

• 1 other identifier: 543.1
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of subjects with clinically relevant changes in vital signs

  up to 8 days after drug administration

• Number of subjects with clinically relevant changes in electrocardiogram

  up to 8 days after drug administration

• Number of subjects with clinically relevant changes in laboratory parameters

  up to 8 days after drug administration

• Number of subjects with adverse events

  up to 8 days after drug administration

• Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)

  up to 72 hours after drug administration

Secondary Outcomes (9)

• Changes in white blood cell count

  up to 48 hours after drug administration

• Changes in differential blood cell count

  up to 48 hours after drug administration

• Maximum plasma concentration (Cmax)

  up to 72 hours after drug administration

• Time to reach maximum plasma concentration (tmax)

  up to 72 hours after drug administration

• Area under the plasma concentration-time curve (AUC) for several time intervals

  up to 72 hours after drug administration

Study Arms (3)

BIIL 284 BS oral solution

EXPERIMENTAL

Drug: BIIL 284 oral solution

BIIL 284 BS WIF tablets

EXPERIMENTAL

Drug: BIIL 284 wetability improved formulation (WIF) tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIL 284 oral solution DRUG

BIIL 284 BS oral solution

BIIL 284 wetability improved formulation (WIF) tablets DRUG

BIIL 284 BS WIF tablets

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects as determined by results of screening
• Age ≥ 21 and ≤ 50 years
• Broca ≥ - 20% and ≤ + 20%
• Signed written informed consent in accordance with Good Clinical Practice and local legislation

You may not qualify if:

• Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
• Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• Known history of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of a drug with a long half-life (≥ 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
• Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
• Participation in another study with an investigational drug within the last two months preceding this study
• Smokers (\> 5 cigarettes or 2 cigars or 2 pipes/day)
• Volunteer who is not able to refrain from smoking on study days
• Alcohol abuse (more than 60 g of alcohol per day)
• Drug abuse
• Excessive physical activities (e.g. competitive sports) within the last week before the study
• Blood donation within the last 4 weeks (≥ 100 ml)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

amelubant; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 15, 2014
• Study Start: June 1, 1998
• Primary Completion: December 1, 1998
• Last Updated: October 15, 2014

Record last verified: 2014-10